The Ebola cure is a turning point in drug development

Two new drugs have shown remarkable promise at treating Ebola in a clinical trial, increasing survival rates for people who recently contracted the disease to between 89 and 94 percent. That’s astonishing for a virus that typically kills about half of all the people it infects.

“From now on we will no longer say that Ebola is not curable. This advance will in the future help save thousands of lives that would have had a fatal outcome in the past,” Jean-Jacques Muyembe, director general of the Democratic Republic of the Congo’s Institut National de Recherche Biomedicale, announced in a press call.

In the aftermath of the discovery, the ongoing outbreak in the Democratic Republic of the Congo is now being viewed by experts not only as a major turning point in Ebola R&D, but also in the way drugs are developed for future emerging diseases. In the past, Ebola has broken out in poor and conflict-ravaged communities that have little access to health care. That’s posed challenges when it comes to securing the investments to fund a cure, and it has made drug trials amid crises even more challenging.

That makes the success of these two drugs all the more exciting to scientists. “This is the first time that a randomized, controlled trial has shown quickly and successfully what the best drugs are in the middle of an ongoing outbreak,” Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health, tells The Verge.

Ebola first emerged more than 40 years ago, and it sparked global fear after massive outbreaks in West Africa between 2014 and 2016 killed more than 11,300 people. Smaller outbreaks have continued, including an ongoing crisis in Congo where nearly 2,800 people have been diagnosed and more than 1,800 people have died. The World Health Organization declared it a public health emergency “of international concern” this July.

Often, in the midst of an epidemic of that scale, Fauci explains, there’s pressure to deploy drugs to the public that may have looked promising in the lab but lacked rigorous clinical trials to prove their safety and efficacy. The outcome of this trial, he contends, is evidence that even in the most challenging situations, studies can be conducted to ensure that a drug is safe.

This particular trial started in November 2018 as part of the international emergency response to the epidemic in Congo. A joint effort by several Congo and international medical organizations enrolled roughly 700 patients to try four experimental drugs. The two more promising treatments are called REGN-EB3 and mAb114, which work by intravenously infusing a combination of monoclonal antibodies into the patient’s blood. The other two drugs, remdesivir and ZMapp, will no longer be administered since they resulted in death rates up to 3 times as high as the other two drugs in patients with low viral loads.

The two Ebola drugs that have succeeded are being offered at no cost for “compassionate use” even though they’re still technically experimental. The process of actually getting a drug through regulatory agencies and into commercial availability is long and cumbersome. Up to 12 years can pass between the time a drug is patented and when it hits the marketplace. And the cost of seeing a single drug through from concept to commercial availability can reach upwards of a billion dollars.

There can be additional hurdles for drugs that treat what are often called “orphan” or “neglected” diseases, which are those that usually afflict communities in the global south that don’t have the funds or political clout to make a drug profitable. Without incentive or investment, drug candidates can get lost in what’s often called the pharmaceutical “valley of death.”

“There is no natural market or demand for a product until an outbreak actually occurs and because outbreaks are sporadic and unpredictable, the size and scope of that market is unclear,” Jamie Bay Nishi, director of the Global Health Technologies Coalition, which advocates for the research and development of neglected diseases, tells The Verge in an email. “Private sector companies have limited incentive to invest proactively, leaving us without tools needed to confront these crises.”
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